But the domestic drug industry behind India’s role as global pharmacist stands to emerge rather poorly from the free trade agreement (FTA) that Europe is proposing for India. In late-stage negotiations over the terms of the long-awaited agreement, the EU is calling for intellectual property rights enforcement that goes well beyond India’s obligations as a member of the World Trade Organisation and would make it all but impossible for generic drug manufacturers in the country to continue in their present structure.

In India, such fears are perilously close to being realised, because the EU-India FTA negotiations are not the only way in which the health of Indian citizens is coming under attack from Europe. In an effort to boost falling profit margins in the west, and to prise open more profitable markets elsewhere, European pharmaceutical companies are also chipping away at India’s judicial system.

That clause has proven to be a literal lifesaver many times since, and it ensured that Novartis’s original case was thrown out of court in 2006. But Novartis has filed new litigation in an attempt to breach India’s legal defences. The final ruling is next month and there is every chance Novartis may succeed. If it does, other pharmaceutical companies will be able to impose higher prices on drugs in India too.

The Novartis case coincides with a third major assault on India’s pharmaceutical industry: the final spear in a triple-pronged attack on its generic drug manufacturers by the west.

This involves the attempt by German pharmaceutical company Bayer to revoke the recent granting of a compulsory licence for an Indian firm, Natco Pharma. The licence was to produce a cheaper version of its anti-cancer drug Sorafenib. Bayer does not manufacture the drug in India, and imports in such small volumes that only a tiny fraction of potential patients could benefit. For its brand, Sorafenib, Bayer has charged Indian patients about $69,000 for a year of treatment, an unaffordable amount for most Indian households. Under the licence, Natco will sell the same medicine at 3% of this price, while paying a licence fee – and still make a profit.

But now Barack Obama’s administration has weighed in on behalf of Bayer’s battle for continued monopoly pricing. Testifying before the House of Representatives subcommittee on intellectual property on 27 June, the deputy director of the US Patent and Trademark Office said US officials are “constantly being there on the ground” pressuring the Indian government to desist from compulsory licensing.

It is not only Indian patients who stand to suffer from this triple-pronged attack. So, too, will charities such as Médecins Sans Frontières, which relies on Indian generic producers to supply 80% of the antiretrovirals it uses around the world. As MSF spokeswoman Leena Menghaney puts it, India is “literally the lifeline of patients in the developing world”. In 2006, MSF launched an international campaign against Novartis, signed by half a million people, including Archbishop Desmond Tutu and the author John le Carré, to get Novartis to drop their pursuit of what the campaign argues is exploitation.

The campaign may not have reckoned on the scale of the assault under way, however. It is not only the pharmaceutical industry that needs to be addressed but the continued and ruthless lobbying by western politicians to secure the profitability of their own industries.

(NaturalNews) Once again, Big Pharma seems to be putting profits over patients, this time in a scheme to prevent cheaper generic drug alternatives from hitting the market sooner. Only this time, the Leviathan is on the side of we, the people.In a friend-of-the-court (amicus) brief, the Federal Trade Commission said makers of name-brand medications that settle challenges to patents by agreeing not to introduce their own generic alternatives are actually using those promises to delay generic competition, Reuters has reported.

In the amicus brief the FTC – a regulatory agency – said such patent settlements, in which drug manufacturers promise not to introduce their own authorized generic drug versions are really just a way of paying a generic rival to keep their products off the market longer.

Conspiracy to delay generic entry into the market

The FTC’s assertions came as a federal court in New Jersey – one that oversees a number of suits against Big Pharma – considers a private antitrust challenge to one such agreement between Pfizer, Inc.’s Wyeth unit and Teva Pharmaceutical Industries Ltd., the world’s biggest manufacturer of drugs.

“Empirical evidence confirms what the pharmaceutical industry has long understood: that a no-(authorized generic) commitment provides a convenient method for branded drug firms to pay generic patent challengers for agreeing to delay entry,” the FTC said in the proposed brief.

A court should “carefully consider the economic realities of no-AG commitments and their impact on consumers,” the agency added.

The regulatory agency filed its brief in support of antitrust litigation filed by chain drugstores CVS Caremark Corp., and Rite Aid Corp., both of which accused Pfizer and Teva of a conspiracy to prevent generic versions of a popular antidepressant, Effexor XR, off store shelves.

In a statement, Pfizers Wyeth subsidiary refuted such allegations, saying its settlement agreement with Teva was correct and proper, and would allow a generic of Effexor XR onto the market a full seven years before its original patent expired.

The company went on to say that the FTC did not voice concerns about the settlement when officials with the agency originally reviewed it.

A spokeswoman from Teva told Reuters the company believes the suit has no merit and as such has filed a motion for dismissal.

But the two drugstore chains aren’t the only retailers who believe something fishy is going on. Walgreen Co., Kroger Co., Safeway Inc., Supervalu Inc. and HEB Grocery Co., had similar misgivings about the settlement in a suit those companies filed in the same court in December.

The presiding judge in the Effexor case sought amicus briefs to assess how the case might be affected by a recent 3rd Circuit Court of Appeals ruling that said payments by a branded drug manufacturer to a potential rival generic drug maker can be “evidence of an unreasonable restraint of trade” if they prevented generic medications – which, of course, are generally much cheaper – out of the hands of patients.

Another case of keeping generics bottled up

This case is far from the first time Big Pharma has tried to keep cheaper, equally effective generic medications off the market.

In July, we reported that an alarming number of Big Pharma corporations are trying to hold on to their patented products for as long as possible – and in more cases, longer than allowed – because they don’t want to see lower-cost options hitting the market.

That month, AstraZenica, was smacked by a federal judge for attempting to block the Food and Drug Administration’s approval of generic versions of its antipsychotic drug Seroquel. The patent for Seroquel expired in March, but the company contended in federal district court in Washington that safety data it provided to the FDA so the agency would approve two additional pediatric uses for the drug forced it to re-label its packaging, reflecting a warning about hyperglycemia (high blood sugar). That re-labeling, attorneys for the drug manufacturer alleged, entitles the company to exclusivity through December 2012.

A federal judge, Beryl A. Howell, disagreed.

“AstraZeneca’s interpretation would create a perverse incentive for pharmaceutical companies to drag out their presentation of vital safety data to the FDA in order to bar generic competition beyond the periods determined acceptable by Congress,” he said in his ruling against the company.

Weak drug regulation and patient tragedies: We’ve seen this story before

Plenty of new drugs, but few that are truly innovative. Growing costs from their use. Physicians deemed “Dupes of Big Pharma” for their interactions with the pharmaceutical industry. A call to produce better information on which drugs work best. Finally, shoddy drug manufacturing is injuring and even killing patients. These stories could be lifted from today’s headlines — but they’re actually from 1962. Problems with the behavior of the pharmaceutical manufacturing industry, and our relationship with it, are not new. Nor are they restricted to one country. Every developed country’s health-care system is different, but one feature is near-universal: none have a public pharmaceutical industry. Ever nation relies on for-profit, private companies to supply its population with drug products.

Blog posts here can get pretty wonkish about health policy, as many of the substantial challenges to science-based medicine have their roots in regulation — whether it’s DSHEA which implemented a regulatory double-standard for supplements, or the state-by-state legislative alchemy that Jann Bellamy has documented, which transforms magical thinking and pseudoscientific practices into registered and regulated health practitioners. Federal food and drug regulations have also come under some scrutiny (and praise). The FDA’s under fire again; this time over its responsibility to oversee pharmaceutical manufacturing. But in this case, it’s not Big Pharma that’s the villan — it’s pharmacies.

From today’s perspective, the FD&C Act (1938) was pretty basic. There was no requirement for manufacturers to demonstrate good manufacturing practices. And if the FDA didn’t move to block a sale within 60 days, a product could be sold. By the 1950′s, it was clear that the Act wasn’t fully effective. Concerns of excessive pricing and questionable evidence statements from manufacturers eventually led to hearings led by Senator Estes Kefauver. Over 18 months an array of new amendments emerged: efficacy claims would be reviewed and approved. Side effects must be reported. Drugs must be approved for sale before any sales could begin. Good drug manufacturing standards would be mandatory, and would be FDA-inspected. Advertising would be monitored. Drugs would have clear generic names, in addition to trade names. All of these proposals made it into the final wording. What’s pretty interesting is what they cut:

Compulsory licensing of generics after 3 years to allow competitive markets

Banning so-called “me-too” drugs — new drugs which failed to offer substantial improvements over existing drugs — would be forbidden, as well as minor modifications to existing chemicals that didn’t offer any therapeutic improvements (hello, Nexium)

Patent approval only where a new drug offered advantages over the current standard treatment — not just demonstrating superiority over placebo

Why did they get cut? As expected, there was strong opposition from pharmaceutical companies. But the American Medical Association also objected, particularly against a greater role for the FDA in evaluating efficacy. The bill was on life support until the thalidomide disaster in 1962 that secured its passage, now called the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetics Act. It effectively set the template for modern-day regulation which has been subsequently emulated around the world. Without these amendments, the requirements for pre-licensing clinical trials probably would not exist. Nor would longer patents, granted in 1984 based on appeals for longer patent protection due to the barriers established before drugs can be sold.

So how did we end up with a meningitis outbreak this year? Through a loophole in the Act. The contamination of injectable steroids is one of a long string of medical harms caused by “compounding pharmacies” — pharmacies that skirt FDA regulations by acting as chameleons. To hospitals and physicians, they’re businesses selling drug products, just like any other pharmaceutical company. But to the FDA, they claim to be pharmacies, not pharmaceutical companies, which put them under the jurisdiction of state pharmacy regulators. Why the loophole? Until fairly recently, all pharmacies used to be compounding pharmacies. Each store made its own dosage forms like creams and capsules. Everything could be personalized. Today, compounding in the pharmacy has dwindled for most products, as Pharma can do it faster, cheaper, and more accurately. But compounding is a legitimate part of pharmacy practice, and can fill real patient care needs. And in an era of regular drug shortages, they can manufacture drug product – but without any of the quality standards mandatory for pharmaceutical companies. Unlike federal requirements which are uniform across the USA and around the world, regulations for pharmacies are determined at the state level, by pharmacy regulators. The same degree of oversight simply does not exist.

It should not be surprising that compounding pharmacies have fought all attempts by the FDA to impose more rigorous manufacturing standards, which would make it harder to sell products. To lawmakers, advocates position it as an access and “right to choose” argument especially for “natural” products like “bioidentical” hormones which are often made by compounding pharmacies. These are the same pharmacies preparing chelation infusions, and they used autistic children to argue for their right to continue to manufacture these products, despite the fact that they are clinically useless for autism. But they seem to work well as a lobbying tool. They’ve successfully killed legislation proposed in 1997, 2003 and again in 2007. This lobbying success is remarkable given there have been no shortage of problems: Since 1990 the Institute for Safe Medication Practice has documented 22 significant pharmacy compounding errors involving 71 different drugs resulting in over 200 adverse events — some fatal.

But is FDA oversight required to keep fungal contamination out of injectable drugs? It shouldn’t be. The United States Pharmacopeia Chapter <797> establishes sterile manufacturing standards which are expected to be adhered to by pharmacies that make these products. Tightening of requirements <797> in 2008 had the effect of causing more outsourcing to larger pharmacies, as smaller centres could not meet the requirements. Probably most concerning is that the requirement to follow <797> isn’t uniform across states — five boards don’t mandate it, and the others don’t audit consistently. That seems to be the case in Massachusetts , where the New England Compounding Center (NECC), has now been closed permanently as it’s revealed that basic safety and manufacturing standards, including <797> requirements were not being followed when it manufactured preservative-free methylprednisolone acetate. The two lots of drug contaminated with black mold have reached 14,000 patients in 23 states. This is no small operation. Furthermore, NECC was flouting state pharmacy law by failing to act as a pharmacy: it shipped product out without a prescription, or labelled for an individual patient.

Conclusion

Regulatory frameworks evolve over time. Regrettably, it sometimes takes a public health catastrophe to give lawmakers the motivation to ignore vested interests and act in the interest of public health. Like the Massengil deaths in the 1930′s, and the thalidomide birth defects in the 1960′s, the New England Compounding Centre may prove to be the impetus for the appropriate regulation of compounding pharmacies. Products manufactured by facilities like NECC should receive the same regulatory oversight, and meet the same manufacturing standards as any other bulk manufactured drug product. What’s clear is that this responsibility cannot be left to the pharmacy profession to manage itself. As I pointed out back in 2010, pharmacy regulators have repeatedly failed to act on the ethical and safety problems with compounding pharmacies. That their inertia has resulted in another public health tragedy is shameful to the profession of pharmacy, and patients across America are quite literally paying the price.